Severe to profound hearing loss is associated with measurable deficits in health-related quality of life (HRQoL), reflecting its concomitant effects o language learning, social and emotional functioning, and academic performance. However, studies of cochlear implantation (CI) typically focus on clinical measures of efficacy related to communication development (e.g., auditory, speech, language skills), which does not represent the intervention's effects on daily functioning. HRQoL measures provide a crucial assessment of the impact of the condition and its treatment on physical, social and emotional functioning. To date, there are no CI-specific HRQoL measures for young children, adolescents and their parents (Morettin et al., 2013). The purpose of this study is to develop the first HRQoL instruments for pediatric cochlear implant recipients and their parents. We plan to complete the first two phases of instrument development for: 1) parents of children birth to five years, 2) school-age children 6-12, plus a parent-proxy measure and 3) adolescents with CIs ages 13-18. Instrument development will adhere to the FDA Guidance on patient-reported outcomes (FDA, 2009). Phase I consists of a synthesis and integration of existing literature and prior HRQoL instruments for this population and data collection at national CI Centers to ensure geographic and racial/ethnic diversity, and includes: 1) an integration of prior literature and instruments to form a testable conceptual framework, 2) focus groups with stakeholders (surgeons, audiologists, speech pathologists), 3) open-ended interviews with parents of children birth to 18 years, children ages 6 to 18 years, and 4) cognitive testing of the 4 draft instruments. Eight one-hour focus groups will be conducted with stakeholders, such as CI surgeons, pediatric audiologists, auditory verbal therapists, and community providers. Next, open-ended interviews will be conducted and audiotaped with 110 parents and children to identify the effects of both deafness and CI use on several areas of functioning. All focus groups and open-ended interviews will be transcribed and content-analyzed to identify key themes and quantify the frequency of their endorsement. Items will then be generated based on saturation matrices of specific content, resulting in draft versions of all four QOL-CI measures. Lastly, cognitive interviews, using standardized think aloud procedures, will be performed with 96 parents and CI users (ages 6 to 18). Cognitive interviewing techniques are now widely used to gain information from respondents about the clarity and comprehensiveness of the items and response scales. Completion of this project will yield the final draft instruments to be field-testd in a national, psychometric validation study to assess reliability, validity, and responsivity to change. Instruments will be developed using an electronic format to enhance their utility and interpretability. These instruments will facilitate evaluation of the effectiveness of CI's over tie, provide patient-centered outcome measures for other interventions (e.g., auditory-verbal therapy, behavioral interventions), and provide information at the patient/family level for targete interventions.